Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT02258646
Registration number
NCT02258646
Ethics application status
Date submitted
2/10/2014
Date registered
7/10/2014
Date last updated
30/04/2019
Titles & IDs
Public title
Long-Term Integrated Telerehabilitation of COPD Patients. A Multi-Center Trial
Query!
Scientific title
Long-Term Integrated Telerehabilitation of COPD Patients. A Multi-Center Randomized Controlled Trial
Query!
Secondary ID [1]
0
0
HST1117-13
Query!
Secondary ID [2]
0
0
228919/DHE
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
iTrain
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Pulmonary Disease, Chronic Obstructive
0
0
Query!
Condition category
Condition code
Respiratory
0
0
0
0
Query!
Chronic obstructive pulmonary disease
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Experimental: Telerehabilitation - Exercise training at home, telemonitoring, and education/self-management
Experimental: Unsupervised exercise training at home - Unsupervised exercise training at home
No intervention: Usual care - Usual care
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Combined number of hospitalizations and emergency department presentations
Query!
Assessment method [1]
0
0
Query!
Timepoint [1]
0
0
Two years
Query!
Secondary outcome [1]
0
0
Hospitalizations
Query!
Assessment method [1]
0
0
Query!
Timepoint [1]
0
0
Two years
Query!
Secondary outcome [2]
0
0
Emergency department presentations
Query!
Assessment method [2]
0
0
Query!
Timepoint [2]
0
0
Two years
Query!
Secondary outcome [3]
0
0
Mortality
Query!
Assessment method [3]
0
0
Query!
Timepoint [3]
0
0
Two years
Query!
Secondary outcome [4]
0
0
Time free from first hospitalization or emergency department presentation
Query!
Assessment method [4]
0
0
Query!
Timepoint [4]
0
0
Two years
Query!
Secondary outcome [5]
0
0
Cost-effectiveness
Query!
Assessment method [5]
0
0
Cost-Utility Analysis (Cost/QALY)
Query!
Timepoint [5]
0
0
Two years
Query!
Secondary outcome [6]
0
0
Change from baseline in COPD Assessment Test at 6 months
Query!
Assessment method [6]
0
0
Query!
Timepoint [6]
0
0
6 months
Query!
Secondary outcome [7]
0
0
Change from baseline in COPD Assessment Test at 1 year
Query!
Assessment method [7]
0
0
Query!
Timepoint [7]
0
0
One year
Query!
Secondary outcome [8]
0
0
Change from baseline in COPD Assessment Test at 2 years
Query!
Assessment method [8]
0
0
Query!
Timepoint [8]
0
0
Two years
Query!
Secondary outcome [9]
0
0
Change from baseline in EQ-5D at 6 months
Query!
Assessment method [9]
0
0
Query!
Timepoint [9]
0
0
Six months
Query!
Secondary outcome [10]
0
0
Change from baseline in EQ-5D at 1 year
Query!
Assessment method [10]
0
0
Query!
Timepoint [10]
0
0
One year
Query!
Secondary outcome [11]
0
0
Change from baseline in EQ-5D at 2 years
Query!
Assessment method [11]
0
0
Query!
Timepoint [11]
0
0
Two years
Query!
Secondary outcome [12]
0
0
Change from baseline in Hospital Anxiety and Depression Scale at 6 months
Query!
Assessment method [12]
0
0
Query!
Timepoint [12]
0
0
Six months
Query!
Secondary outcome [13]
0
0
Change from baseline in Hospital Anxiety and Depression Scale at 1 year
Query!
Assessment method [13]
0
0
Query!
Timepoint [13]
0
0
One Year
Query!
Secondary outcome [14]
0
0
Change from baseline in Hospital Anxiety and Depression Scale at 2 years
Query!
Assessment method [14]
0
0
Query!
Timepoint [14]
0
0
Two years
Query!
Secondary outcome [15]
0
0
Change from baseline in Generalized Self-Efficacy Scale at 6 months
Query!
Assessment method [15]
0
0
Query!
Timepoint [15]
0
0
Six months
Query!
Secondary outcome [16]
0
0
Change from baseline in Generalized Self-Efficacy Scale at 1 year
Query!
Assessment method [16]
0
0
Query!
Timepoint [16]
0
0
One year
Query!
Secondary outcome [17]
0
0
Change from baseline in Generalized Self-Efficacy Scale at 2 years
Query!
Assessment method [17]
0
0
Query!
Timepoint [17]
0
0
Two years
Query!
Secondary outcome [18]
0
0
Change from baseline in 6- minute walking distance at 6 months
Query!
Assessment method [18]
0
0
Query!
Timepoint [18]
0
0
Six months
Query!
Secondary outcome [19]
0
0
Change from baseline in 6- minute walking distance at 1 year
Query!
Assessment method [19]
0
0
Query!
Timepoint [19]
0
0
One year
Query!
Secondary outcome [20]
0
0
Change from baseline in 6- minute walking distance at 2 years
Query!
Assessment method [20]
0
0
Query!
Timepoint [20]
0
0
Two years
Query!
Secondary outcome [21]
0
0
Change from baseline in physical activity at 6 months
Query!
Assessment method [21]
0
0
Query!
Timepoint [21]
0
0
Six months
Query!
Secondary outcome [22]
0
0
Change from baseline in physical activity at 1 year
Query!
Assessment method [22]
0
0
Query!
Timepoint [22]
0
0
One year
Query!
Secondary outcome [23]
0
0
Change from baseline in physical activity at 2 years
Query!
Assessment method [23]
0
0
Query!
Timepoint [23]
0
0
Two years
Query!
Secondary outcome [24]
0
0
Patient Global Impression of Change after 2 years
Query!
Assessment method [24]
0
0
Query!
Timepoint [24]
0
0
Two years
Query!
Secondary outcome [25]
0
0
Hospitalizations at 1 year
Query!
Assessment method [25]
0
0
Query!
Timepoint [25]
0
0
One year
Query!
Secondary outcome [26]
0
0
Emergency department presentations at 1 year
Query!
Assessment method [26]
0
0
Query!
Timepoint [26]
0
0
One year
Query!
Secondary outcome [27]
0
0
Mortality at 1 year
Query!
Assessment method [27]
0
0
Query!
Timepoint [27]
0
0
One year
Query!
Eligibility
Key inclusion criteria
* Diagnosis of COPD
* At least one COPD-related hospitalization or COPD-related emergency department presentation in the previous 12 months to enrollment
* Capable to provide signed written informed consent
Query!
Minimum age
40
Years
Query!
Query!
Maximum age
80
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
* Attendance to a rehabilitation program in the previous 6 months of enrollment
* Participation in another study that may have an impact on the outcome of this study
* Deemed by the health care team to be physically uncapable to perform the study procedures
* Presence of comorbidities wich might prevent the patient from safely undertake an exercise program at home
* Home environment not suitable for installation and use of rehabilitation and monitoring equipment (e.g. physical space, Wi-FI Internet or mobile Internet via 4G)
Query!
Study design
Purpose of the study
Other
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people assessing the outcomes
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
NA
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
1/10/2014
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
1/12/2018
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
120
Query!
Recruitment in Australia
Recruitment state(s)
VIC
Query!
Recruitment hospital [1]
0
0
The Alfred - Melbourne
Query!
Recruitment postcode(s) [1]
0
0
3181 - Melbourne
Query!
Recruitment outside Australia
Country [1]
0
0
Denmark
Query!
State/province [1]
0
0
Esbjerg
Query!
Country [2]
0
0
Norway
Query!
State/province [2]
0
0
Tromsø
Query!
Funding & Sponsors
Primary sponsor type
Other
Query!
Name
University Hospital of North Norway
Query!
Address
Query!
Country
Query!
Other collaborator category [1]
0
0
Other
Query!
Name [1]
0
0
The Research Council of Norway
Query!
Address [1]
0
0
Query!
Country [1]
0
0
Query!
Other collaborator category [2]
0
0
Other
Query!
Name [2]
0
0
The Royal Norwegian Ministry of Health
Query!
Address [2]
0
0
Query!
Country [2]
0
0
Query!
Other collaborator category [3]
0
0
Other
Query!
Name [3]
0
0
LHL Helse
Query!
Address [3]
0
0
Query!
Country [3]
0
0
Query!
Other collaborator category [4]
0
0
Other
Query!
Name [4]
0
0
University of Tromso
Query!
Address [4]
0
0
Query!
Country [4]
0
0
Query!
Other collaborator category [5]
0
0
Other
Query!
Name [5]
0
0
La Trobe University
Query!
Address [5]
0
0
Query!
Country [5]
0
0
Query!
Other collaborator category [6]
0
0
Other
Query!
Name [6]
0
0
The Alfred
Query!
Address [6]
0
0
Query!
Country [6]
0
0
Query!
Other collaborator category [7]
0
0
Other
Query!
Name [7]
0
0
Aalborg University
Query!
Address [7]
0
0
Query!
Country [7]
0
0
Query!
Other collaborator category [8]
0
0
Other
Query!
Name [8]
0
0
Esbjerg Hospital - University Hospital of Southern Denmark
Query!
Address [8]
0
0
Query!
Country [8]
0
0
Query!
Other collaborator category [9]
0
0
Government body
Query!
Name [9]
0
0
Esbjerg Municipality
Query!
Address [9]
0
0
Query!
Country [9]
0
0
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
This research project aims to conduct a three-arm multi-center randomized controlled trial (RCT) on an innovative telerehabilitation intervention for patients with chronic obstructive pulmonary disease (COPD). The overall purpose of the RCT is to demonstrate whether long-term integrated telerehabilitation involving exercise training at home, telemonitoring, and education/self-management will prevent hospital readmissions, thus reducing healthcare costs, for patients with COPD, and will improve patient status and quality of life.
Query!
Trial website
https://clinicaltrials.gov/study/NCT02258646
Query!
Trial related presentations / publications
Cox NS, Dal Corso S, Hansen H, McDonald CF, Hill CJ, Zanaboni P, Alison JA, O'Halloran P, Macdonald H, Holland AE. Telerehabilitation for chronic respiratory disease. Cochrane Database Syst Rev. 2021 Jan 29;1(1):CD013040. doi: 10.1002/14651858.CD013040.pub2. Hoaas H, Zanaboni P, Hjalmarsen A, Morseth B, Dinesen B, Burge AT, Cox NS, Holland AE. Seasonal variations in objectively assessed physical activity among people with COPD in two Nordic countries and Australia: a cross-sectional study. Int J Chron Obstruct Pulmon Dis. 2019 Jun 5;14:1219-1228. doi: 10.2147/COPD.S194622. eCollection 2019. Zanaboni P, Dinesen B, Hjalmarsen A, Hoaas H, Holland AE, Oliveira CC, Wootton R. Long-term integrated telerehabilitation of COPD Patients: a multicentre randomised controlled trial (iTrain). BMC Pulm Med. 2016 Aug 22;16(1):126. doi: 10.1186/s12890-016-0288-z.
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Paolo Zanaboni, PhD
Query!
Address
0
0
University Hospital of North Norway
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT02258646
Download to PDF